Spinal MetastasesNCT06244264
The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
A study testing Autoblood transfusion in people with Spinal Metastases and Blood Transfusion Complication, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The goal of this single-center prospective randomized controlled trial is to test and compare the safety and effectiveness of autologous blood transfusion in spinal surgery for lung cancer spinal metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Metastases, Blood Transfusion Complication, Lung Cancer
- What is being tested?
- Autoblood transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age range is 18-75 years old;
- The pathological diagnosis was lung cancer and spinal metastatic tumor;
- Expected survival > 3 months, can tolerate surgery;
- Unstable spine; And/or spinal cord nerve compression, nerve function; Progressive decline, palliative spinal open decompression surgery
- Patients with intraoperative/postoperative Hb<90 g/L or other conditions requiring blood transfusion
Who cannot join
- Serious heart dysfunction or heart failure, diagnosed blood system diseases, coagulation disorders;
- Severe renal insufficiency or need hemodialysis treatment;
- Sepsis or septicemia;
- Unable to obtain consent from the patient or family.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong provincial people's hospital
Guangzhou, Guangdong, 516008
Guoqing Zhong, M.D., gqzhong@foxmail.com
About this study
Official title: A Single-center, Prospective, Randomized Controlled Study of the Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
The goal of this single-center prospective randomized controlled trial is to test and compare the safety and effectiveness of autologous blood transfusion in spinal surgery for lung cancer spinal metastases. The main questions it aims to answer are:
- Does autologous blood transfusion increase the incidence of new metastases?
- Does autologous blood transfusion affect postoperative hemoglobin levels and the number of circulating tumor cells in the blood?
- Can autologous blood transfusion reduce the rate of allogeneic transfusion during and after surgery for spinal metastases?
Read the detailed description
In this study, participants underwent standard open spinal decompression surgery, and when blood transfusion was needed, autologous blood transfusion or allogeneic blood transfusion was used. Participants will be patients with lung cancer spinal metastases. Investigators will use flow cytometry, immunohistochemistry, and tumor cell culture methods to measure the number of circulating tumor cells in the blood before and after autologous blood transfusion.
Investigators will compare participants who receive autologous blood transfusion with those who do not to observe if there are differences in:
- The incidence of new metastases
- The rate of allogeneic transfusion during and after surgery
- Postoperative hemoglobin levels
- The number of circulating tumor cells in the blood
- The cost associated with transfusion
- Conditions
- Spinal Metastases, Blood Transfusion Complication, Lung Cancer, Surgery, Autologous Blood Transfusion
- Being tested
- Autoblood transfusion
- Medical subject headings
- Transfusion Reaction, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autoblood transfusionProcedure or surgery
Through a negative pressure suction device, the patient's blood that flows out during surgery is collected into a blood storage filter. During the suction process, it is mixed with an appropriate anticoagulant and passed through multiple layers of filters. When the volume of recovered blood reaches a certain level, it is continuously (or intermittently) centrifuged. Using a high-speed centrifugal blood recovery tank, the red blood cells are separated, and the plasma, waste, cell fragments, anticoagulants, and harmful components are diverted into a waste bag. A large amount of saline is used to repeatedly wash, purify, and concentrate the red blood cells. Finally, the concentrated red blood cells are prepared into a 70% red blood cell suspension with saline and stored in a collection bag for transfusion back to the patients. Open surgery is considered as the standard procedure for metastatic spinal cord compression
| Study group | Role | What they receive |
|---|---|---|
| Autoblood transfusion + leukocyte filter group | Experimental | In our department open surgery is considered as the standard procedure. The patients underwent open surgery, with autologous blood transfusion combined with a leukocyte filter. Blood transfusion based on bleeding during surgery. Receives: Procedure: Autoblood transfusion |
| Allogeneic blood transfusion group | No intervention | In our department open surgery is considered as the standard procedure. The patients receives open surgery with allogeneic blood transfusion. Blood transfusion based on bleeding during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative and postoperative allogeneic blood transfusion rate
The number of allogeneic blood transfusion patients (Intraoperative or postoperative )/ the total number of patients
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Number of circulating tumor cells in the blood
Number of circulating tumor cells in the blood
Measured: within 30 days post-surgery
Incidence of transfusion related adverse reactions
the number of adverse reactions/ the total number of patients
Measured: within 14 days post-surgery
occurence of new lesions
the number of patients with occurence of new lesions / the total number of patients
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start15 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized parallel controlled study
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Zhang, PhD, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244264
- Sponsor's protocol ID
- SPMAT001
- Status last verified
- Jul 2024
- First submitted
- 15 Jan 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the research is completed, the data may be publicly shared depending on the outcome.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Randomized Controlled Study of the Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
- ClinicalTrials.gov ID
- NCT06244264
- Acronym / sponsor ID
- SPMAT001
- Conditions
- Spinal Metastases, Blood Transfusion Complication, Lung Cancer, Surgery, Autologous Blood Transfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this single-center prospective randomized controlled trial is to test and compare the safety and effectiveness of autologous blood transfusion in spinal surgery for lung cancer spinal metastases. The main questions it aims to answer are:
- Does autologous blood transfusion increase the incidence of new metastases?
- Does autologous blood transfusion affect postoperative hemoglobin levels and the number of circulating tumor cells in the blood?
- Can autologous blood transfusion reduce the rate of allogeneic transfusion during and after surgery for spinal metastases?
Detailed description
In this study, participants underwent standard open spinal decompression surgery, and when blood transfusion was needed, autologous blood transfusion or allogeneic blood transfusion was used. Participants will be patients with lung cancer spinal metastases. Investigators will use flow cytometry, immunohistochemistry, and tumor cell culture methods to measure the number of circulating tumor cells in the blood before and after autologous blood transfusion.
Investigators will compare participants who receive autologous blood transfusion with those who do not to observe if there are differences in:
- The incidence of new metastases
- The rate of allogeneic transfusion during and after surgery
- Postoperative hemoglobin levels
- The number of circulating tumor cells in the blood
- The cost associated with transfusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized parallel controlled study
| Arm | Type | Receives |
|---|---|---|
| Autoblood transfusion + leukocyte filter group | Experimental | Procedure: Autoblood transfusionIn our department open surgery is considered as the standard procedure. The patients underwent open surgery, with autologous blood transfusion combined with a leukocyte filter. Blood transfusion based on bleeding during surgery. |
| Allogeneic blood transfusion group | No intervention | –In our department open surgery is considered as the standard procedure. The patients receives open surgery with allogeneic blood transfusion. Blood transfusion based on bleeding during surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age range is 18-75 years old;
- The pathological diagnosis was lung cancer and spinal metastatic tumor;
- Expected survival > 3 months, can tolerate surgery;
- Unstable spine; And/or spinal cord nerve compression, nerve function; Progressive decline, palliative spinal open decompression surgery
- Patients with intraoperative/postoperative Hb<90 g/L or other conditions requiring blood transfusion
Key exclusion criteria (4 listed)
- Serious heart dysfunction or heart failure, diagnosed blood system diseases, coagulation disorders;
- Severe renal insufficiency or need hemodialysis treatment;
- Sepsis or septicemia;
- Unable to obtain consent from the patient or family.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autoblood transfusionThrough a negative pressure suction device, the patient's blood that flows out during surgery is collected into a blood storage filter. During the suction process, it is mixed with an appropriate anticoagulant and passed through multiple layers of filters. When the volume of recovered blood reaches a certain level, it is continuously (or intermittently) centrifuged. Using a high-speed centrifugal blood recovery tank, the red blood cells are separated, and the plasma, waste, cell fragments, anticoagulants, and harmful components are diverted into a waste bag. A large amount of saline is used to repeatedly wash, purify, and concentrate the red blood cells. Finally, the concentrated red blood cells are prepared into a 70% red blood cell suspension with saline and stored in a collection bag for transfusion back to the patients. Open surgery is considered as the standard procedure for metastatic spinal cord compression | Procedure or surgery | Autoblood transfusion + leukocyte filter group |
Primary outcome
Intraoperative and postoperative allogeneic blood transfusion rate
Time frame: Through study completion, an average of 1 year
The number of allogeneic blood transfusion patients (Intraoperative or postoperative )/ the total number of patients
3 secondary outcomes
Number of circulating tumor cells in the blood
Time frame: within 30 days post-surgery
Incidence of transfusion related adverse reactions
Time frame: within 14 days post-surgery
occurence of new lesions
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No. After the research is completed, the data may be publicly shared depending on the outcome.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autoblood transfusion in people with Spinal Metastases and Blood Transfusion Complication, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang, Ph.D. (8613602744495, luck_2001@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative and postoperative allogeneic blood transfusion rate (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.